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LAWSUITS NEWS & LEGAL INFORMATION

FDA Issues Class 1 Recall of Zimmer M/L Taper with Kinectiv Technology Prosthesis


Washington, DC: The US Food and Drug Administration (FDA) and Zimmer have issued a Class 1 recall of the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are Tivanium® alloy implants used for hip replacements.

The company found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.

The implants allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck.

The affected products were made and distributed between March 31, 2015 and April 20, 2015.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.



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